Study on Tagraxofusp and Azacitidine With or Without Venetoclax for Newly Diagnosed Secondary AML After Previous Treatment

Inclusion Criteria

• Must have newly diagnosed, untreated acute myeloid leukemia (AML) with a specific percentage of cancer cells in the blood or bone marrow.
• Must have leukemia cells that test positive for a marker called CD123.
• Must have a documented history of certain blood disorders and have received at least two cycles of specific treatments for these conditions.
• White blood cell count must be below a certain level before starting treatment.
• Must be 18 years or older.
• Must be in good overall health with a performance status score of 0 to 2.
• Must have adequate organ function and heart health.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
• Must not have active HIV, hepatitis B, or hepatitis C infections unless they are well-controlled.
• Must be able to understand and agree to the study procedures and provide written consent.

Exclusion Criteria

• Cannot participate if suitable for intensive chemotherapy and willing to receive it.
• Cannot have a specific type of leukemia called acute promyelocytic leukemia.
• Cannot have leukemia that has spread to the central nervous system.
• Cannot have previously received Tagraxofusp.
• Cannot have received certain treatments or investigational drugs within a specified time before the study.
• Cannot have had a stem cell transplant within the last 60 days.
• Cannot be on certain immunosuppressive therapies unless they meet specific conditions.
• Cannot have had other cancers within the last two years, with some exceptions.
• Cannot have significant heart or lung diseases that are not well-controlled.
• Cannot have active, uncontrolled infections.
• Cannot be pregnant or breastfeeding.
• Cannot have other severe medical or psychiatric conditions that would interfere with the study.